Deputy Secretary of the Health Products Regulation Group (HPRG) in the Department of Health, John Skerritt, and the Head of the Office of Drug Control (ODC), Bill Turner attended information sessions around Australia last week to provide further insight into the framework under which medicinal cannabis may be cultivated and medicinal cannabis products produced and supplied to patients in Australia once new legislation is introduced later this year.
Professor Skerritt began by reiterating the importance of understanding the structure and interaction of two arms of the HPRG, the Therapeutic Goods Administration (TGA) and the ODC, in order to understand how Australians will be able to cultivate, produce and manufacture medicinal cannabis under the Narcotic Drugs Amendment Act 2016 (Cth) (Act).
The Act passed through Parliament in record time in February, and since that time the TGA, ODC and Australian Border Force have engaged in ongoing consultation to build and implement the processes to facilitate medicinal cannabis activities to commence in Australia after 31 October 2016.
Although the ODC is yet to publish the relevant Regulations and Guidelines that will underpin the Act, it is now possible to map out the likely structure and substance of these publications, and subsequently the likely (and numerous) requirements for Australians to successfully obtain licences and permits under the Act, and maintain compliance with all of the applicable laws and regulations.
We emphasise “all” because the applicable laws and regulations are numerous and include the Act, Regulations and Guidelines (which must comply with the Single Convention on Narcotic Drugs 1961), the Therapeutic Goods Act 1989 (TG Act), the Poisons Standard (and the appropriate State and Territory reiterations of these), and the various legislation in each of the States and Territories which additionally regulate manufacture and supply of medicinal cannabis products in those jurisdictions.
Obligations and responsibilities established under these laws and regulations are significant for any person or company looking to get involved in medicinal cannabis cultivation, production, manufacture or supply in Australia. Importantly, applicants for licences and permits must be able to demonstrate end-to-end supply of medicinal cannabis through a supply chain for cultivation of medicinal cannabis, processing of raw material, manufacture of finished products and supply to patients by prescription through an authorised prescriber or under one of the permitted exemptions under the TG Act and Therapeutic Goods Regulations 1990. In this regard, every part of the supply chain must be able to prove they it is meeting a legitimate and quantifiable demand. This is central to the government’s intention to implement the Act and ensure that “every leaf is used legitimately”.
The medicinal cannabis supply chain under the Act will comprise the following general elements which incorporate separate, but interdependent obligations and responsibilities on licensees: cultivation and production manufacture and supply to patients.
Firstly, persons or companies who wish to obtain a licence to cultivate or produce medicinal cannabis will require a licence and a permit under the Act which necessitates evidence of the applicant’s personal, financial and experiential capacity to engage in medicinal cannabis activities. Prospective cultivators should be aware that they will only be permitted to obtain seeds from specific authorised sources and that the ODC estimates that the size of cultivation facilities is significantly smaller than what has been circulated in the media and opinion pieces.
Secondly, persons or companies who wish to manufacture medicinal cannabis products will require up to three licences and a permit which will deal separately with:
a) the manufacturer’s security and recording requirements;
b) the manufacturer’s responsibility for meeting and maintaining certain safety and quality standards as regulated by the TGA; and
c) the manufacturer’s obligations under separate State and Territory law for manufacturing within their jurisdiction.
Finally, the TGA and the Department of Health in each State and Territory will need to identify patient groups who will be eligible to receive medicinal cannabis products. Although this is not confirmed, Mr Turner confirmed that the Commonwealth intends to “[place] the medical profession at the centre of decisions [regarding patient access to medicinal cannabis]”. In this regard, and considering the delegate’s interim decision regarding the scheduling status of cannabis, it is highly likely that supply of medicinal cannabis to patients will occur predominantly via the existing schemes for access to unapproved therapeutic goods, with additional restrictions.
In addition to describing the framework, Mr Turner briefly discussed how persons or companies will access application forms under the Act, the potential fees and charges which will apply, the term of licences approved under the Act and requirements for re-application and how the framework ensures medicinal cannabis products are not at risk of diversion or other criminal activity. Mr Turner confirmed that there is likely to be a future for medicinal cannabis exports from Australia, which the ABF will play an important role in developing, but that domestic patient demand is the main priority for this year.